Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument…

Recall date
September 11, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0113-2016
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US (nationwide) and Canada.

Why it was recalled

small puncture marks in a sterile package for an accessory to an Olympus device

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

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